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FDA 510(k)

VITREA VERSION 4.0

K-Number: K071331 · 2007-05-25

ApplicantVital Images, Inc.
Decision Date2007-05-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VITREA VERSION 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Vital Images, Inc.. It received FDA 510(k) clearance on 2007-05-25 under 510(k) number K071331. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITREA VERSION 4.0?

VITREA VERSION 4.0 is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Vital Images, Inc.. The 510(k) number is K071331.

When did VITREA VERSION 4.0 receive FDA 510(k) clearance?

VITREA VERSION 4.0 received FDA 510(k) clearance on 2007-05-25, under 510(k) number K071331.

Who is the listed applicant for VITREA VERSION 4.0?

The FDA 510(k) record lists Vital Images, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITREA VERSION 4.0?

The FDA product code for VITREA VERSION 4.0 is LLZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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